TY  - JOUR
AU  - Dam, Tien
AU  - Boxer, Adam L
AU  - Golbe, Lawrence I
AU  - Höglinger, Günter
AU  - Morris, Huw R
AU  - Litvan, Irene
AU  - Lang, Anthony E
AU  - Corvol, Jean-Christophe
AU  - Aiba, Ikuko
AU  - Grundman, Michael
AU  - Yang, Lili
AU  - Tidemann-Miller, Beth
AU  - Kupferman, Joseph
AU  - Harper, Kristine
AU  - Kamisoglu, Kubra
AU  - Wald, Michael J
AU  - Graham, Danielle L
AU  - Gedney, Liz
AU  - O'Gorman, John
AU  - Haeberlein, Samantha Budd
TI  - Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial.
JO  - Nature medicine
VL  - 27
IS  - 8
SN  - 1546-170X
CY  - New York, NY
PB  - Nature America Inc.
M1  - DZNE-2021-01399
SP  - 1451 - 1457
PY  - 2021
AB  - A randomized, double-blind, placebo-controlled, 52-week study (no. NCT03068468) evaluated gosuranemab, an anti-tau monoclonal antibody, in the treatment of progressive supranuclear palsy (PSP). In total, 486 participants dosed were assigned to either gosuranemab (n = 321) or placebo (n = 165). Efficacy was not demonstrated on adjusted mean change of PSP Rating Scale score at week 52 between gosuranemab and placebo (10.4 versus 10.6, P = 0.85, primary endpoint), or at secondary endpoints, resulting in discontinuation of the open-label, long-term extension. Unbound N-terminal tau in cerebrospinal fluid decreased by 98
KW  - Aged
KW  - Antibodies, Monoclonal, Humanized: adverse effects
KW  - Antibodies, Monoclonal, Humanized: therapeutic use
KW  - Double-Blind Method
KW  - Female
KW  - Humans
KW  - Male
KW  - Pneumonia: etiology
KW  - Supranuclear Palsy, Progressive: drug therapy
KW  - Treatment Outcome
KW  - tau Proteins: immunology
KW  - Antibodies, Monoclonal, Humanized (NLM Chemicals)
KW  - MAPT protein, human (NLM Chemicals)
KW  - tau Proteins (NLM Chemicals)
KW  - gosuranemab (NLM Chemicals)
LB  - PUB:(DE-HGF)16
C6  - pmid:34385707
DO  - DOI:10.1038/s41591-021-01455-x
UR  - https://pub.dzne.de/record/162743
ER  -